HRSA-26-092 Final.pdf

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Hereditary Hemorrhagic Telangiectasia (HHT) Center
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HRSA-26-092
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This is a Notice of Funding Opportunity (NOFO) for the Hereditary Hemorrhagic Telangiectasia (HHT) Center program issued by the Health Resources and Services Administration (HRSA) Maternal and Child Health Bureau. The program seeks to fund one cooperative agreement to establish a national HHT center that will improve care for this rare genetic disorder through a network of at least 15 clinical centers providing multidisciplinary treatment, quality improvement initiatives, and a de-identified patient data registry. The application deadline is July 10, 2026, with an expected award date of August 2, 2026, and a project start date of September 1, 2026. The total available funding is $2,900,000 for a three-year period of performance ending August 31, 2029, with awards funded in three budget periods.

Eligible applicants include state governments and unrestricted domestic organizations located in the 50 states, U.S. territories, and freely associated states. The funded center must establish data use agreements with clinical partners, develop and maintain a national HHT patient registry compliant with HIPAA and cybersecurity standards, pilot an EHR alert system to identify potential HHT patients, conduct quality improvement projects focused on expanding access and improving quality of life, provide provider education, and engage persons with lived experience including patients and families in all aspects of the program. Applications are limited to 50 pages and must include a detailed work plan, staffing plan, logic model, organizational chart, biographical sketches of key staff, agreements with clinical centers, and a comprehensive budget narrative. Recipients must comply with 2 CFR Part 200 regulations, maintain performance data, submit annual progress reports, and participate in DGIS reporting to demonstrate achievement of program objectives.

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Notice of Funding Opportunity

Application due 07/10/2026

MATERNAL AND CHILD HEALTH BUREAU

Hereditary Hemorrhagic Telangiectasia (HHT) Center

HRSA-26-092

Table of Contents Before You Begin

Step 1: Review the Opportunity

Basic information

Funding details

Eligibility

Program description

Award information

Step 2: Get Ready to Apply

Get registered

Find the application package

Application writing help

Step 3: Build Your Application

Application checklist

Application contents and format

Step 4: Understand Review, Selection, and Award

Application review

Selection process

Award notices

Step 5: Submit Your Application

Application submission and deadlines

Other submissions

Step 6: Learn What Happens After Award

Post-award requirements and administration

Reporting

Contacts and Support

Agency contacts

Help with systems

Before You Begin Health Resources and Services Administration

Maternal and Child Health Bureau

Division of Services for Children with Special Health Needs (DSCSHN)

Opportunity name: Hereditary Hemorrhagic Telangiectasia (HHT) Center

Opportunity number: HRSA-26-092

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings. Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate: racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety. If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

Step 1: Review the Opportunity Basic information Tagline: Strengthening access to HHT care through clinical centers

Summary This funding aims to support one center that will work to improve care for Hereditary Hemorrhagic Telangiectasia (HHT) to reduce illness and death by:

• Partnering with at least 15 clinical centers that specialize in treating HHT to expand access and coordination of care for HHT patients seen by multidisciplinary teams.

• Leading clinical centers in quality improvement projects aimed at improving quality of life for individuals with HHT and expanding access to care for the HHT population.

• Developing a de-identified, aggregate patient data registry to better understand HHT and treatment outcomes.

• Developing, implementing, or improving patient registry data extraction from clinical center EHR systems.

• Piloting an EHR enhancement alert system within clinical centers that assists with identifying and diagnosing potential HHT patients and can prevent clinical complications.

Have questions? Go to Contacts and Support.

Key facts

Opportunity name:

Hereditary Hemorrhagic Telangiectasia (HHT) Center

Opportunity number:

HRSA-26-092

Announcement version:

initial

Federal assistance listing:

93.110

Key dates

NOFO issue date:

06/08/2026

Informational webinar:

See Join the webinar

Application deadline:

07/10/2026

Expected award date:

08/02/2026

Expected start date:

09/01/2026

See other submissions for other time frames that may apply to this NOFO.

Funding details Application Types:

Competing continuation New Expected total available funding in FY:

2026: $2,900,000

Expected number and type of awards:

1 CA (Cooperative Agreement)

Funding range per award:

$0 - $2,900,000

We plan to fund awards in three budget periods for a period of performance from 09/01/2026 to 08/31/2029.

The program and awards depend on the appropriation of funds and are subject to change based on the availability and amount of appropriations.

Eligibility You can apply if you’re located in an eligible state or represent a domestic* organization.

Types of eligible organizations These types of domestic organizations may apply:

State governments

Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility”

Additional information on eligibility

“Domestic” means the 50 states, the District of Columbia, the Commonwealth of Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.

Individuals are not eligible applicants under this NOFO.

Completeness and responsiveness criteria We will review your application to make sure it meets these basic requirements to move forward in the competition.

We will not consider an application that:

• Is from an organization that does not meet all eligibility criteria.

• Requests funding above the award ceiling shown in the funding range.

• Is submitted after the deadline.

• Exceeds the 50-page limit. HRSA will not review any pages that exceed the page limit.

Application limits You may not submit more than one application. If you submit more than one application, we will only accept the last on-time submission.

Cost sharing This program has no cost-sharing requirement. If you choose to share in the costs of the project, we will not consider it during merit review. Recipients agree that once committed, cost sharing amounts are enforceable and subject to reporting and auditing requirements under 2 CFR 200.

Post-award requirements

Before you apply, make sure you understand the requirements that come with an award.

See Step 6: Learn What Happens After Award for information on regulations that apply, reporting, and more.

Program description Purpose The purpose of the HHT Center Program is to reduce illness and death related to HHT by:

• Partnering with at least 15 clinical centers that specialize in treating HHT to expand access and coordination of care for HHT patients seen by multidisciplinary teams.

• Leading clinical centers in quality improvement projects aimed at improving quality of life for individuals with HHT and expanding access to care for the HHT population.

• Developing a de-identified, aggregate patient data registry to better understand HHT and treatment outcomes.

• Developing, implementing, or improving patient registry data extraction from clinical center EHR systems.

• Piloting an EHR enhancement alert system within clinical centers that assists with identifying and diagnosing potential HHT patients and can prevent clinical complications.

Funding Opportunity Goals

• The program aims to strengthen the system of services for people with HHT, their families, and caregivers by establishing a national center supporting comprehensive care and expand access to care for the HHT population. This care includes screening, diagnosis, and treatment to improve health outcomes. One of the Make America Healthy Again (MAHA) initiatives include addressing the root causes of the chronic disease epidemic, rather than treating symptoms alone. HRSA's HHT Center Program expands patient access to coordinated care and long-term management of a rare and chronic condition, consistent with MAHA's broader prevention health goals.

By August 31, 2029, the program aims to achieve the following objectives:

1. Increase the percentage of patients seen by a multidisciplinary HHT team in each clinical center's catchment area, including those from communities with limited access to care, by 15%.

2. 100% of clinical centers enter data into a national HHT patient registry maintained by the funding recipient.

3. 100% of clinical centers participate in continuous quality improvement projects related to improving quality of life for people with HHT and expand access to care for the HHT population.

4. At least five clinical centers will electronically transfer de-identified patient data from their EHR systems to the national HHT patient registry.

Background HHT is a rare genetic disorder. It causes abnormal blood vessel formation[1] on the surface of the skin, lining of the nose and intestinal tract, and in the liver, lungs, and brain.[2] These blood vessels can burst and bleed,[3] causing serious issues like embolic stroke, brain abscess, pulmonary hypertension, and other respiratory complications. [4] 10% of patients die from complications.[5] The disorder affects roughly 1 in 5,000 people.[6] HHT can impact anyone, regardless of age, sex, or ethnicity.5

HHT can be hard to diagnose. Symptoms like nosebleeds may be mistaken for other conditions.

HHT also varies by person. The time from first symptom to diagnosis can be as long as 27 years.[7]

Specialists from many fields care for people with HHT because the disease impacts multiple parts of the body. Outcomes for people with HHT are better when specialists work together as teams. There are currently no Food and Drug Administration (FDA)-approved therapeutics for the treatment of HHT.

Congress stated in its FY2026 Departments of Labor, Health and Human Services, Education, and Related Agencies (Labor HHS) Appropriations Act Report that $3 million should be used for the HHT Program. This NOFO addresses this report and builds on the prior funding opportunity.

It aims to reduce illness and death from HHT by expanding access and coordination of care and analyzing data to better inform clinicians on how to diagnose and treat HHT cases.

Program requirements and expectations This program is expected to improve the system of services for people with HHT, including those in communities with limited access to care.

You must propose strategies for all of the following activities:

• HHT Network of clinical centers o Establish a network of at least 15 clinical centers to expand access to care and support comprehensive teams that provide care to HHT patients and their families.

You must include the names of the 15 clinical centers and Memorandum of Understandings (MOU) or Letters of Support (LOS) in your application. A template of the MOU and a list of the 15 clinical centers may be included in the application to minimize the number of pages of the application. After award, all final MOUs must be provided to HRSA.

o Provide sufficient oversight and financial assistance to network clinical centers to expand treatment access and increase the number of individuals with HHT served.

You may provide subawards to qualified clinical centers that can fulfill the goals and requirements of this program.

o All network clinical centers must provide clinical evaluation, treatment, and education to patients and their families or caregivers.

o All network clinical centers must collect and submit data to the national HHT patient data registry.

• National HHT patient data registry o Develop, maintain, and use a patient data registry to better understand HHT and support the advancement of new diagnostic and treatment options.

The registry must comply with Health Industry Cybersecurity Practices[1] for managing cyber threats and protecting patient data.

The HHS 405(d) Program offers Healthcare and Public Health (HPH) sector resources and guidance, which must be consulted in developing the patient registry. These are focused on providing organizations across the nation with useful and impactful HPH-focused resources, products, and tools that help educate, raise awareness, and provide vetted cybersecurity best practices and strengthen the sector’s cybersecurity posture against cyber threats.

The registry must adhere to all applicable privacy laws, including Health Insurance Portability and Accountability Act (HIPAA) General Administrative and Privacy and Security Requirements detailed in 45 CFR Part 160 through Part 164. The following provisions also apply: Sections 1171-1180 of the Social Security Act (the Act), sections 262 and 264 of https://www.appropriations.senate.gov/imo/media/doc/fy26_lhhs_jes.pdf https://www.appropriations.senate.gov/imo/media/doc/fy26_lhhs_jes.pdf https://405d.hhs.gov/ https://405d.hhs.gov/

Public Law 104-191, section 105 of Public Law 110-233, sections 13400- 13424 of Public Law 111-5, and section 1104 of Public Law 111-148.

The registry must include clear safeguards to protect sensitive patient data from unauthorized access, breaches, or misuse.

The registry must follow the Office of the National Coordinator’s (ONC’s) Interoperability Standards (standards that allow systems to share and use data) Advisory (ISA), and more information about this is in the section on Health information technology interoperability.

The registry must contain common data elements and data standards.

The registry must follow the FAIR principles[2] for data management that make sure data within the registry is findable, accessible, interoperable, and reusable.

o Work with the National Institutes of Health (NIH)-funded Rare Diseases Clinical Research Network’s Data Management Coordination Center (DMCC) to learn more about development, maintenance, and use of rare disease registries.

Incorporate industry level interoperability standards used for rare disease data collection into the patient data registry.

If your organization does not have access to an existing national registry, instead of creating a standalone registry, consider collaborating with another organization or the DMCC in developing a national HHT patient registry to meet all required federal, state, and institutional regulations governing interoperability, and patient privacy and security standards.

After award, you must work with HRSA to obtain approval for your approach in developing the patient data registry.

o Establish data use agreements with network clinical centers.

Develop a diagram that summarizes the flow of data in and out of the national HHT registry, that also includes who has access, the security measures in place, how collaborators will use the data, and how other stakeholders in the field, HRSA funded recipients, and the federal government will have access to de-identified patient registry.

Establish data use agreements that reflect this data flow.

• EHR enhancements o Pilot an EHR alert system in participating clinical centers to identify and diagnose potential HHT patients and prevent complications.

o Establish, improve, and or refine a method to transfer data from network clinical center EHRs to the selected national registry used for this work.

o Ensure that all EHR enhancements meet ONC interoperability standards, as provided for in the ISA and by applicable state and federal laws and regulations.

o Conduct quality improvement activities to assess EHR enhancements and their impact on clinic operations including but not limited to process improvement, care delivery, and care coordination.

• Quality of Life/Continuous Quality Improvement (CQI) https://www.govinfo.gov/link/plaw/104/public/191 https://www.govinfo.gov/link/plaw/110/public/233 https://www.govinfo.gov/link/plaw/111/public/5 https://www.govinfo.gov/link/plaw/111/public/148 o Create and report on quality-of-life metrics guided by people with lived experience, including people with HHT and their families and caregivers.

o Involve clinical centers in efforts to improve HHT patients’ quality of life and expand access to care for the HHT population.

o Support clinical centers in implementing CQI projects that improve quality of life for individuals with HHT.

o Annually report on each center’s CQI projects.

• Engagement of Persons with Lived Experience (PWLE) o Involve PWLE with HHT and their families/caregivers in program activities in each of the 15 clinical centers.

Their engagement may focus on giving feedback about care quality, patient registries, and identifying unmet needs, particularly in areas with limited access to care.

• Advisory Committee o Establish and maintain an advisory committee for the national center.

o It must include clinicians and PWLE who have firsthand experience about HHT who provide input on all grant activities.

• Provider education o Provide ongoing education and technical assistance to clinicians to improve knowledge about diagnosis, referrals, and treatment for HHT. Clinicians may include hematologists, pulmonologists, gastroenterologists, genetic counselors, primary care physicians, school nurses, etc.

o Share tools and resources to support clinicians who are part of the care team for HHT patients.

• Communication o Create and implement a communication and collaboration plan to share best practices across the clinical center network.

o Develop a plan to identify and address national patient-centered care challenges and gaps.

• Follow the guidance in the Performance measurement, evaluation, and continuous quality improvement (CQI) section.

Performance measurement, evaluation, and continuous quality improvement (CQI)

We expect you to measure your performance, evaluate your program, and conduct CQI activities.

Actions include:

• Measuring performance on key activities and program objectives.

o Annually collect and report data on the program objectives listed above and the

Discretionary Grants Information System (DGIS) measures in the Reporting section.

o Each clinical center must identify the number of people living with HHT in their catchment area to report on NOFO objectives.

bookmark://Reporting/ o Develop and implement an evaluation plan to assess the impact of grant activities and use the data to make improvements to the program.

o Conducting CQI activities to improve processes and outcomes.

Reporting Requirements:

1. Annually collect and report in the non-competing continuation progress report and DGIS on:

• Engagement of PWLE who have firsthand knowledge of HHT.

• Meeting interoperability and privacy/security standards for the national HHT registry.

• Collaboration with the DMCC on the national HHT registry.

• Patients’ quality of life.

• Identifying HHT patients through the EHR enhancement alert system.

• Provider education.

Statutory authority Title V, Section 501(a)(2) of the Social Security Act (42 U.S.C. 701(a)(2)), as amended

[1] Alkhalid, Y. et al. (2023). “Multidisciplinary coordinated care of hereditary hemorrhagic telangiectasia (Osler-Weber-Rendu Disease).” Vascular Medicine, 28(2), 153-165.

https://pubmed.ncbi.nlm.nih.gov/36890671/

[2]Centers for Disease Control and Prevention. “About Hereditary Hemorrhagic Telangiectasia (HHT). Available at https://www.cdc.gov/hht/about/index.html. Accessed 11/12/24.

[3] Medline Plus. “Hereditary Hemorrhagic Telangiectasia.” Available at https://medlineplus.gov/genetics/condition/hereditary-hemorrhagic-telangiectasia/#resources.

Accessed 11/12/24.

[4] De Gussem, E.M. et al. (2016). “Life expectancy of parents with Hereditary Hemorrhagic Telangiectasia.” Orphanet Journal of Rare Disease, 46(2016).

https://ojrd.biomedcentral.com/articles/10.1186/s13023-016-0427-x.

[5] Lessnau, K.-D. (2020). “Ossler-Weber-Rendu Disease (Hereditary Hemorrhagic Telangiectasia).” Medscape. Available at https://emedicine.medscape.com/article/2048472-overview#a7?form=fpf. Accessed 7/26/24.

[6] Faughnan, M.E. et. Al. (2020). “Second International Guidelines for the Diagnosis and Management of Hereditary Hemorrhagic Telangiectasia.” Annals of Internal Medicine, 173(12).

https://www-acpjournals-org.ezproxyhhs.nihlibrary.nih.gov/doi/10.7326/M20-1443.

[7]Cuesta, M.A. (2022). “Hereditary Hemorrhagic Telangiectasia: Diagnosis and Management.”

Journal of Clinical Medicine, 11(16):4698. https://pmc.ncbi.nlm.nih.gov/articles/PMC9410055/.

[1] HHS 405(d) Aligning Health Care Industry Security Approaches.

https://405d.hhs.gov/cornerstone/hicp. Accessed 4/3/25.

https://www.govinfo.gov/content/pkg/COMPS-8759/pdf/COMPS-8759.pdf https://uscode.house.gov/view.xhtml?req=(title:42%20section:701%20edition:prelim) https://pubmed.ncbi.nlm.nih.gov/36890671/ https://www.cdc.gov/hht/about/index.html https://medlineplus.gov/genetics/condition/hereditary-hemorrhagic-telangiectasia/#resources https://ojrd.biomedcentral.com/articles/10.1186/s13023-016-0427-x https://emedicine.medscape.com/article/2048472-overview#a7?form=fpf https://emedicine.medscape.com/article/2048472-overview#a7?form=fpf https://www-acpjournals-org.ezproxyhhs.nihlibrary.nih.gov/doi/10.7326/M20-1443 https://pmc.ncbi.nlm.nih.gov/articles/PMC9410055/ https://405d.hhs.gov/cornerstone/hicp

[2] Wilkinson, M.D. et al. (2016). “The FAIR Guiding Principles for scientific data management and stewardship.” Scientific Data. 3:160018.

https://pmc.ncbi.nlm.nih.gov/articles/PMC4792175/

Award information Cooperative agreement terms Our responsibilities Aside from monitoring and technical assistance, we also get involved in these ways:

• Participate in planning and developing project activities through meetings during the period of performance.

• Review policies, procedures, activities, emerging issues, data, measures, and tools.

• Provide approval for approach in developing the patient data registry.

• Collaborate and approve all public facing documents, findings, best practices, lessons learned, reports, articles, and presentations related to the work developed under this

NOFO.

• Conduct site visits.

• Monitor performance data to track progress, provide feedback, and assess outcomes.

o HRSA and the recipient will work together after the award to finalize the monitoring and accountability approach.

• Support your collaboration with national centers and grantees funded by the Division of Services for Children with Special Health Needs (DSCSHN).

Your responsibilities You must follow all relevant laws and policies. Your other responsibilities will include:

• Completing activities described in this NOFO.

• Meeting with the HRSA project officer at the time of award and throughout the project period to review current strategies and progress.

• Producing and sharing project findings by publishing articles, reports, or presentations.

• Adhering to HRSA guidelines related to acknowledgment and disclaimer on all products produced by HRSA awards (Refer to Communicating and Acknowledging Federal Funding for how to comply.).

• Analyzing evidence-informed and CQI data, impact, and any relevant data trends.

• Collaborating with HRSA to review activities, budget items, procedures, information, and publications prior to them being shared.

• Collaborating with other federally funded entities like NIH’s DMCC, DSCSHN’s Family

Engagement and Leadership in Systems of Care, and others.

• Seeking approval from HRSA regarding the patient registry and following all relevant federal, state and institutional data requirements for registries and maintaining confidentiality of patient data.

Funding policies and limitations Changes in HHS regulations As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75.

https://pmc.ncbi.nlm.nih.gov/articles/PMC4792175/ https://www.hrsa.gov/grants/manage-your-grant/acknowledge-hrsa-funding https://www.hrsa.gov/grants/manage-your-grant/acknowledge-hrsa-funding https://www.ecfr.gov/current/title-2/part-200

Policies

• To make an award, funding must be available and allocated for this program and purpose, at which point we will move forward with the review and award process.

• Have clear policies and good financial practices to avoid spending HRSA funds on unallowable activities. Like other award rules, we may audit your policies, procedures, and controls.

• If we receive more funding for this program, we may:

o Fund more applicants from the rank order list.

o Extend the period of performance.

o Award supplemental funding.

General limitations

• For guidance on some types of costs we do not allow or restrict, see o Project Budget Information in the Application Guide.

o 2 CFR Part 200 Subpart E - General Provisions for Selected Items of Cost.

o Allowable and Unallowable Costs and Activities in the HHS Grants Policy

Statement.

• All costs must be reasonable, necessary, allocable to the award, and adequately documented (2 CFR 200.403).

• You cannot earn profit from the federal award. See 2 CFR § 200.400(g).

• Current appropriations law includes a salary limit of $228,000 as of January 2026 that applies to this program. You may pay salaries at a higher rate if the rate beyond the salary rate limit (Executive Level II) is paid with non-HHS funds.

Program-specific statutory or regulatory limitations

• Foreign travel: No foreign travel (using federal award dollars or federal program income) is allowed.

See Manage Your Grant for other information on costs and financial management.

Indirect costs Indirect costs are costs you charge across more than one project that cannot be easily separated by project. For example, this could include utilities for a building that supports multiple projects.

To incur indirect costs, you can select one of two methods:

Method 1 – Approved rate. You currently have an indirect cost rate approved by your cognizant federal agency at the time of award.

Method 2 – De minimis rate. Per 2 CFR § 200.414(f), if you do not have a current negotiated indirect cost rate, you may elect to charge a de minimis rate. If you choose this method, costs included in the indirect cost pool must not be charged as direct costs.

This rate is up to 15% of modified total direct costs (MTDC). See 2 CFR § 200.1 for the definition of MTDC. You can use this rate indefinitely for all your federal awards or until you choose to receive a negotiated rate.

Consider your indirect costs when developing your budget.

https://www.hrsa.gov/sites/default/files/hrsa/grants/application-guide.pdf#page=13 https://www.ecfr.gov/current/title-2/part-200/subject-group-ECFRed1f39f9b3d4e72 https://www.ecfr.gov/current/title-2/part-200/subject-group-ECFRed1f39f9b3d4e72 https://www.hhs.gov/grants-contracts/grants/grants-policies-regulations/index.html https://www.hhs.gov/grants-contracts/grants/grants-policies-regulations/index.html https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200/subpart-E/subject-group-ECFRea20080eff2ea53/section-200.404 https://www.ecfr.gov/current/title-2/section-200.405 https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200/subpart-E/subject-group-ECFRea20080eff2ea53/section-200.403 https://www.ecfr.gov/current/title-2/part-200#p-200.400(g) https://www.hrsa.gov/grants/manage-your-grant https://www.ecfr.gov/current/title-2/section-200.414 https://www.ecfr.gov/current/title-2/part-200#p-200.1(Modified%20Total%20Direct%20Cost%20(MTDC))

Program income Program income is money earned as a result of your award-supported project activities. You must use any program income you generate from awarded funds for approved project-related activities. Find more about program income at 2 CFR 200.307.

• If we receive more funding for this program, we may:

o Fund more applicants from the rank order list.

o Extend the period of performance.

o Award supplemental funding.

Step 2: Get Ready to Apply

Get registered SAM.gov You must have an active account with SAM.gov to apply. SAM.gov registration can take several weeks. Begin that process today.

To register:

• Go to SAM.gov Entity Registration and select Get Started. From the same page, you can also select the Entity Registration Checklist for the information you will need to register.

• You must agree to the financial assistance general certifications and representations specifically. Those for contracts are different.

When you register, you will also receive your required Unique Entity Identifier (UEI).

Once you register:

• You will have to maintain your registration throughout the life of any award.

• If your organization has multiple UEIs, use the one associated with your physical location.

If you need additional information about user roles in SAM.gov, see “Get registered: SAM.gov user roles” in the Application Guide.

Grants.gov You must also have an active account with Grants.gov. You can see step-by-step instructions at the Grants.gov Quick Start Guide for Applicants and How to Apply for Grants.

Find the application package The application package has all the forms you need to apply. You can find it online. Go to Grants Search at Grants.gov and search for opportunity number HRSA-26-092.

After you select the opportunity, we recommend that you click the Subscribe button to get updates.

Application writing help Visit HHS Tips for Preparing Grant Proposals.

Visit HRSA’s How to Prepare Your Application page for more guidance.

https://www.ecfr.gov/current/title-2/section-200.307 https://sam.gov/content/entity-registration https://www.hhs.gov/sites/default/files/financial-assistance-general-certification-representations.pdf https://www.hrsa.gov/sites/default/files/hrsa/grants/application-guide.pdf#page=4 https://grants.gov/applicants/applicant-registration http://www.grants.gov/quick-start-guide/applicants https://www.grants.gov/applicants/grant-applications/how-to-apply-for-grants https://www.grants.gov/search-grants https://www.grants.gov/search-grants https://www.hhs.gov/grants-contracts/grants/get-ready-for-grants-management/tips-for-preparing-grant-proposals/index.html https://www.hrsa.gov/grants/apply-for-a-grant/prepare-your-application

See Apply for a Grant for other help and resources.

FAQs will be posted on our TA webpage after the webinar with a link to Grants.gov Related Documents tab.

Join the webinar For more information about this opportunity, join the webinar. More information on the HRSA- 26-092 webinar will be posted at a later date to the related documents tab on Grants.gov.

We recommend that you “Subscribe” to the NOFO on Grants.gov to receive updates when we post documents.

We will record the webinar.

Have questions? Go to Contacts and Support.

Step 3: Build Your Application

Application checklist There are two types of forms in Grants.gov.

• Some forms allow you to upload components of your application to the form. These include components like your project narrative, budget and budget narrative, and attachments, as applicable.

• Other forms are more typical, fill-in-the-blank forms.

Make sure that you have everything you need to apply.

Narratives

Component Grants.gov form Included in page limit*?

Project Abstract Use the Project Abstract Summary form. No

◻ Project narrative

Use the Project Narrative Attachment form.

Project Narrative Attachment form. Yes

◻ Budget narrative

Use the Budget Narrative Attachment form.

Budget Narrative Attachment form. Yes

Attachments Insert each in the Attachments form. Yes

Other required forms Upload using each required form. Yes Attachments Insert each in the Attachments Form in this order.

Component Included in page limit*?

https://www.hrsa.gov/grants/apply-for-a-grant

◻ 1. Work plan Yes ◻ 2. Staffing plan and job descriptions Yes ◻ 3. Biographical sketches Yes ◻ 4. Agreements with other entities Yes ◻ 5. Project organizational chart Yes ◻ 6. Registry Standards of Interoperability Yes ◻ 7. Tables and charts Yes ◻ 8. Other relevant document Yes ◻ 9. Other relevant document Yes ◻ 10. Other relevant document Yes ◻ 11. Other relevant document Yes ◻ 12. Other relevant document Yes ◻ 13. Other relevant document Yes ◻ 14. Other relevant document Yes ◻ 15. Other relevant document Yes Other required forms Upload using each required form in Grants.gov.

Forms Submission requirement Application for Federal Assistance (SF-424) With application.

Project Abstract Summary Form With application.

Grants.gov Lobbying Form With application.

Disclosure of Lobbying Activities (SF-LLL), optional With application.

Project/Performance Site Location(s) With application.

Budget Information for Non-Construction Programs (SF 424A) With application.

Key Contacts With application.

*Only what you attach in these forms counts toward the page limit. The forms themselves do not count.

Application contents and format This section includes guidance on each component found in the application checklist.

Application page limit: 50

Submit your information in English and express whole number budget figures using U.S. dollars.

Required format Required format for project summary, project narrative, budget narrative, and attachments.

Font: A readable font like Arial, Courier, CG Times, or Times New Roman

File format: We only accept the following document formats:

• .PDF - Adobe Portable Document Format

• .DOC/.DOCX - Microsoft Word

• .RTF - Rich Text Format o .TXT - Text

• .WPD - Word Perfect Document

• .XLS/.XLSX - Microsoft Excel

• .VSD - Microsoft Visio

Size: 12-point font Footnotes, charts, graphics, and budget tables may be 10-point or higher.

Ink color: Black

Spacing: Single-spaced, including all text and tables

Alignment: Left

Headings: Bold all headings and align left.

Size: 8.5 x 11 (Make sure the print area is set and allows printing to 8.5 x 11.)

Margins: 1-inch on all sides

Footer: On each page as the footer, include your organization’s name and page numbers. If a competing continuation or competing supplement, also include your 10-digit award number.

Page numbering:

• Do not number the standard OMB-approved forms.

• Number each attachment page sequentially (that is, 1, 2, 3).

• Reset the numbering for each attachment.

• Treat each attachment as a separate section.

File names: You can find guidance for naming your files in the Application Guide.

Project narrative Introduction See merit review criterion 1: Need

Briefly describe the purpose of your project.

Need See merit review criterion 1: Need

• Document the challenges people with HHT face, such as unmet health needs, access issues, coordination needs, desired outcomes, and emerging issues.

• Outline the HHT community’s needs you plan to address.

• Include information on populations experiencing the greatest health challenges, including due to community impact factors, such as rurality.

• Discuss barriers that you hope to overcome.

• Use and cite demographic data whenever possible.

Approach https://www.hrsa.gov/sites/default/files/hrsa/grants/application-guide.pdf#page=26

See merit review criterion 2: Response

• Tell us how you’ll address the needs you described and meet the program requirements and expectations described in this NOFO.

Include plans to partner with clinical centers and support ongoing staff training, teamwork, and sharing information.

• Plan and develop a national HHT Patient Data Registry that:

o Provides details on the interoperability and security standards that will be included.

o Collaborates with the DMCC.

o Shows how data will be safeguarded, meeting all applicable federal, state and institutional regulations.

o Shows how the registry will work with EHR systems.

• Describe how you will form an advisory committee and find potential members, including PWLE who have firsthand knowledge of HHT.

• Include plans for outreach and collaboration to involve individuals with lived experience who have firsthand knowledge of HHT, as well as their families, caregivers, and communities.

• Provide a timeline for how EHR enhancements will be implemented and a plan to roll out quality improvement activities to improve clinic operations using EHR enhancements.

• Include a plan to support clinical centers in quality improvement projects that improve the quality of life for people with HHT and expand access to care for the HHT population.

• Include a plan to distribute reports, products, or project outputs to target audiences.

• Propose a plan for continuing the project when federal funding ends.

o We expect you to continue key strategies or services and actions that have led to improved practices and outcomes for the target population.

• Describe how you will manage and securely store data, including how you will protect data against cybersecurity threats, misuse, breaches, or other loss of data integrity.

• Describe how you will ensure patient registry data privacy and security, and how you will obtain clinical center data use agreements.

High-level work plan See merit review criteria 2: Response and 4: Impact

• Describe how you’ll achieve each objective during the period of performance.

• Include a detailed work plan in Attachment 1.

o Include a timeline for each activity and assign a responsible person.

o As needed, identify how key stakeholders will help plan, design, and carry out these activities.

You will also include a more detailed work plan in your attachments.

Logic Models

See merit review criteria 2: Response and 4: Impact

Submit a logic model for your project. A logic model is a one-page diagram that presents a conceptual framework and explains the links between program elements.

This specific logic model should summarize the connections between the:

• Goals of the project (e.g., reasons for proposing the intervention, if applicable)

• Assumptions (e.g., beliefs about how the program will work and support resources; base assumptions on research, best practices, and experience).

• Inputs (e.g., organizational profile, collaborative partners, key personnel, budget, other resources).

• Target population (e.g., the individuals to be served).

• Activities (e.g., approach, listing key intervention, if applicable).

• Outputs (i.e., the direct products of program activities).

• Outcomes (i.e., the results of a program, typically describing a change in people or systems).

Although there are similarities, a logic model is not a work plan. A work plan is an action, how-to guide with a timeline and steps used during program implementation.

You can reference the Logic Model Tip Sheet. The work plan and logic model should be submitted as Attachment 1 .

Resolving challenges See merit review criterion 2: Response

Discuss possible challenges you may face in designing and carrying out the activities in the work plan. Explain approaches that you’ll use to resolve them. Specifically, discuss how you will resolve challenges related to:

• Determining a clinical center’s catchment area denominator (the total individuals living with HHT) and your solutions.

• Creating a registry that follows all federal regulations, and how you will comply with registry security, data safeguards, and protections against data breaches.

• Transferring patient registry data from clinical centers’ EHR systems and your solutions.

• Piloting an EHR enhancement alert system for clinical centers to identify possible HHT patients and your solutions.

Performance management See merit review criteria 3: Performance reporting and evaluation

Outcomes. Describe the expected outcomes (desired results) of the funded activities.

• Performance measurement and reporting. See our reporting manual for performance measure requirements and examples of reporting forms.

o Describe how you will collect and report required performance data on time and without errors.

https://www.acf.hhs.gov/sites/default/files/documents/prep-logic-model-ts_0.pdf o Describe how you will monitor and analyze performance data to improve your program.

o In addition, describe your plans to annually report key performance measures such as:

HHT Patients

The percentage of new and returning HHT patients seen by each clinical center in their catchment area, broken down by demographic subgroups.

This includes a numerator (which is the number of patients seen by the clinical center in their catchment area), a denominator, (which is the number of individuals with HHT estimated to live in the catchment area), and the percentage of the population reached for each relevant demographic subgroup.

Aggregate de-identified data that show health outcomes and best practices (data should be broken down by demographic groups).

National HHT Patient Registry The percentage of clinical centers that are entering patient data in the registry.

The percentage of the 15 clinical centers that transferred patient registry data from their EHR systems.

EHR Enhancements The percentage of clinical centers piloting an EHR enhancement function to identify possible HHT patients and prevent complications.

The percentage of clinical centers implementing quality improvement activities to evaluate EHR enhancements and their impact on clinic operations.

Quality of Life/CQI The percentage of clinical centers participating in CQI projects addressing quality of life and expanding access to care for people with HHT.

The number of quality-of-life metrics created and implemented that reflect the needs of people with lived experience who have firsthand knowledge of HHT and their families and caregivers.

The percentage of clinical centers who have implemented EHR enhancements and have improved clinic operations.

Provider Education The percentage of unique medical providers who reported increased knowledge about HHT and its treatment.

This data should be broken down by characteristics such as provider role or specialty.

o Explain your plan and ability to collect data on the measures specified by HRSA MCHB in the Program requirements and expectations.

• Program evaluation. Describe how you will evaluate your project. The evaluation should examine processes and progress towards goals, program objectives, and expected outcomes. Evaluations must follow the HHS Evaluation Policy, as well as the standards and best practices described in OMB Memorandum M-20-12. In the description of your evaluation, include:

o The evaluation questions, methods, data you will collect, and timeline for evaluating the program.

o Challenges in evaluating your program and how you will address them.

o The capacity of your organization and staff to evaluate the program. Include their experience, skills, and knowledge.

o How you will share results, how you will assess whether you are sharing results effectively, whether your results are national in scope, and whether other organizations can replicate your program.

o Describe the systems and processes that you’ll use to track performance outcomes.

Describe how you’ll collect and manage data (e.g., assigned skilled staff, data management software) in a way that allows for accurate and timely reporting of those outcomes.

o Describe the quality and feasibility of your proposed measures, how they align with the purpose of this NOFO, and how they will assess performance and progress towards the program goals and objectives.

o Describe how these measures can be used to attribute results to the project.

o Describe how you will report performance measurement and evaluation findings, use them to show the outcomes of this NOFO, and apply them for continuous program quality improvement.

o Describe your plans to monitor progress and conduct quality improvement efforts to make sure the program meets the needs of people with HHT and their families.

See the reporting section for more information.

Sustainability See merit review criterion 4: Impact

We expect you to sustain key project elements that improve practices and outcomes for the target population. Propose a plan for project sustainability after the period of federal funding ends.

• Highlight key elements of your projects.

o Examples include training methods or strategies that have been effective in improving practices.

• Describe the actions you will take to obtain future sources of funding that do not include HRSA funding.

• Set a timeline to become self-sufficient.

• Describe a plan to integrate proposed activities into routine practice at the network clinic level so that federal funding is no longer needed.

https://aspe.hhs.gov/reports/department-health-human-services-evaluation-policy https://www.whitehouse.gov/wp-content/uploads/2020/03/M-20-12.pdf o For example, how CQI becomes part of managed care practices.

o Discuss challenges that you’ll likely encounter in sustaining the program.

o Include how you will resolve these challenges.

o Describe how you plan to collaborate with rare disease networks or other registries to make the project sustainable.

Organizational information See merit review criterion 5: Resources and capabilities

Briefly describe your organization’s mission, structure, and the scope of your current activities.

Explain how they will help you carry out the program requirements. Include a project organizational chart in Attachment 4.

• Describe your key staff’s experience, skills, and knowledge.

o Include a staffing plan and job descriptions for key personnel in Attachment 2.

• Provide a description of the organizational capacity to gather, manage, and use data.

• Explain your experience with performance reporting and program evaluation.

• Describe the quality of the facilities you will use to carry out the project.

• Discuss how you’ll follow the approved project, keep track of all federal funds, and record all costs to avoid issues during the project audit.

• Include plans to partner with DMCC.

Budget and budget narrative See merit review criterion 6: Support requested

Your budget should follow the instructions in budget narrative: detailed instructions section of the Application Guide and the instructions listed in this section. Your budget should show a well-organized plan.

HHS now uses the definitions for equipment and supply in 2 CFR 200.1. The new definitions change the threshold for equipment to the lesser of the recipient’s capitalization level or $10,000 and the threshold for supplies to below that amount.

The total project or program costs are all allowable (direct and indirect) costs used for the HRSA award activity or project. This includes costs charged to the award and non-federal funds used to satisfy a matching or cost-sharing requirement (which may include maintenance of effort, if applicable).

The budget narrative supports the information you provide in Standard Form 424-A. It includes an itemized breakdown and a clear justification of the costs you request. The merit review committee reviews both.

As you develop your budget, consider:

• If the costs are reasonable, allowable and allocable, and consistent with your project’s purpose and activities.

• The restrictions on spending funds. See funding policies and limitations.

https://www.ecfr.gov/current/title-2/part-200#p-200.1(Equipment) https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200#p-200.1(Supply)

• Appropriate support to clinical centers to participate in the registry, develop EHR linkage and reporting to the registry.

To create your budget narrative, see budget narrative detailed instructions in the Application Guide.

Attachments Place your attachments in this order in the Attachments Form. See application checklist to determine if they count toward the page limit.

Unless the instructions below require it, do not submit organizational brochures or other promotional materials (for example, slides, films, clips).

Attachment 1: Work Plan Attach the project’s detailed work plan. Make sure it includes everything required in the project narrative section.

Also include the required logic model in this attachment.

If you will make subawards or expend funds on contracts, describe how your organization will ensure that it uses funds for appropriate purposes (e.g., through a subrecipient monitoring plan).

Attachment 2: Staffing plan and job descriptions Include a staffing plan that shows the staff positions that will support the project, and key information about each. Justify your staffing choices, including their education and experience.

Explain your reasons for the amount of time you request for each staff position.

For each key staff member, attach a one-page job description. It must include their role, responsibilities, and qualifications.

Attachment 3: Biographical sketches Include biographical sketches for people who will hold the key positions you describe in Attachment 2.

Each biographical sketch should be no more than two pages. Do not include non-public, personally identifiable information. If you include someone you have not hired yet, provide a letter of commitment from that person along with the biographical sketch.

Attachment 4: Agreements with other entities Provide MOUs or LOS that describe working relationships between your organization and others you mention in your project narrative.

If you include documents that confirm actual or pending contracts or agreements, the documents should clearly describe the roles of subrecipients and contractors, as well as any deliverables.

You do not need to include all parts of lengthy agreements if the parts that you include describe the working relationship between you and the other organization.

Ensure that authorized officials sign and date all letters of agreement.

Provide a one-page diagram that shows the full project’s organizational structure.

Attachment 6: Tables and charts https://grants.gov/learn-grants/grant-terminology#p

Provide tables or charts that give more detail about the national HHT registry and the standards that will be used to support the registry. Include information about how you will manage and securely store data, including how you will protect data against cybersecurity threats, breaches, or other loss of data integrity.

Attachment 7: Registry Standards of Interoperability Provide tables or charts that give more detail about the proposal. These might be Gantt, PERT, or flow charts.

Attachment 8-15: other relevant documents You may use attachments 8 through 15 to add other relevant documents.

Other required forms

You will need to complete some other forms. Upload the following forms at Grants.gov. You can find them in the NOFO application package or review them and any available instructions at Grants.gov Forms.

Forms Submission requirement Application for Federal Assistance (SF-424) With application.

Project Abstract Summary Form With application.

Grants.gov Lobbying Form With application.

Disclosure of Lobbying Activities (SF- LLL), optional With application.

Project/Performance Site Location(s) With application.

Budget Information for Non-Construction Programs (SF 424A) With application.

Key Contacts With application.

Form instructions The application guide has detailed instructions for:

• The Application for Federal Assistance (SF-424).

• The Budget Information for Non-Construction Programs (SF-424A).

Project abstract summary form instructions Complete the information in the Project Abstract Summary form. Include a short description of your proposed project. Include the needs you plan to address, the proposed services, and the population groups you plan to serve.When writing your summary:

Use 4,000 characters or fewer.

Make sure it’s clear, accurate, short.

Do not refer to other parts of the application.

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